Latest News in the pharma Industry

Policy & Regulation

Amgen and UCB submit BLA for romosozumab to the FDA

Amgen and UCB submit BLA for romosozumab to the FDA

22 Jul 2016

Based on Phase III FRAME Study in postmenopausal women with osteoporosis.

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Mylan and Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by EMA

Mylan and Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by EMA

21 Jul 2016

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FDA expands indication for type 2 diabetes treatment Synjardy

FDA expands indication for type 2 diabetes treatment Synjardy

19 Jul 2016

Expanded indication now includes treatment-naïve adults.

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SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA

SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA

18 Jul 2016

The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe.

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Allergan files application to FDA for approval of Oculeve Intranasal Tear Neurostimulator

Allergan files application to FDA for approval of Oculeve Intranasal Tear Neurostimulator

18 Jul 2016

A first of its kind approach to increasing tear production in patients suffering from dry eye disease.

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Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

14 Jul 2016

Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product.

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Pfizer receives FDA approval for Prevnar 13 in adults age 18 through 49

Pfizer receives FDA approval for Prevnar 13 in adults age 18 through 49

13 Jul 2016

Prevnar 13 is the only pneumococcal vaccine approved in the US for patients 6 weeks through adulthood.

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FDA Approves Shire’s Xiidra

FDA Approves Shire’s Xiidra

12 Jul 2016

Xiidra is the only treatment Indicated for the signs and symptoms of dry eye disease.

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Scots first to receive breakthrough immunotherapy for lung cancer

Scots first to receive breakthrough immunotherapy for lung cancer

11 Jul 2016

Eligible patients in Scotland will be the first in the UK to access this life-extending treatment and will be ahead of those patients in England and Wales.

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FDA approves first and only single monthly injection for a PCSK9 inhibitor

FDA approves first and only single monthly injection for a PCSK9 inhibitor

11 Jul 2016

Amgen's Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge) provides a new, monthly single-dose administration option.

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EC grants marketing authorization for Gilead’s Epclusa for the treatment of all genotypes of chronic hepatitis C

EC grants marketing authorization for Gilead’s Epclusa for the treatment of all genotypes of chronic hepatitis C

10 Jul 2016

Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus infection and is Gilead’s third Sofosbuvir-based treatment.

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FDA approves Genentech’s Xolair for allergic asthma in children

FDA approves Genentech’s Xolair for allergic asthma in children

8 Jul 2016

Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma.

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